DCGI suspends approvals to Axis for violating drug trial rules

Hyderabad: The Drugs Controller General of India (DCGI) has suspended various approvals to Axis Clinicals for its alleged involvement in conducting illegal clinical trials for a cancer drug on women in the State.

The trials were conducted for all Bio-availability and Bio-equivalence studies at the company’s centres in Miyapur, Hyderabad. It carried out the studies on Exemestane tablets between 27 January and 15 February.

It was alleged that the firm administered the anti-cancer drug to poor women in Piduguralla town of Andhra Pradesh without securing their informed consent.

Ministry of Health and Family Welfare said in a statement, “The investigations have revealed various irregularities in conduct of the above said studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process.”

It said the investigations were conducted on 20 and 21 June at the Bio-equivalence study centre of Axis. DCGI has therefore suspended its approval for conducting all Bio-availability and Bio-equivalence studies at its centres.

South Zone Office of DCGI in Chennai and Sub-zonal office here has conducted investigations about certain irregularities in conduct of clinical study by Axis, in violation of the norms specified in Schedule Y of the Drugs and Cosmetics Rule.

Besides, DCGI has decided to investigate the working of all Bio-availability and Bio-equivalence study centres in Andhra Pradesh within two months to ensure that such trials are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines.